DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ preliminary amendment filed on April 25, 2024, is acknowledged. Claims 11-20 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 10, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 recites: A recombinant construct for screening drugs against SARS-CoV-2 spike protein having SEQ ID NO: 2. The claim is rejected because it is ambiguous. The claim can be read in two ways, a) SEQ ID NO: 2 being the SARS-CoV-2 protein and b) SEQ ID NO: 2 being the recombinant construct. SEQ ID NO: 2 is a nucleic acid sequence and thus it is part of the recombinant construct. Applicant is suggested to amend the claim to recite: A recombinant construct for screening drugs against SARS-CoV-2 spike protein, said recombinant construct comprising the nucleic acid of SEQ ID NO: 2.
Claim 12 recites: The recombinant construct of claim 11, comprising:(i) a fusion protein having SEQ ID NO:1 (ii) a designed substrate; and (iii) a reporter protein. The recombinant construct typically comprises a nucleic acid encoding the protein, not a protein. Applicant is suggested to amend claim 12 to recite: The recombinant construct of claim 11, comprising the nucleic acid of SEQ ID NO: 2 encoding :(i) a fusion protein having SEQ ID NO:1, (ii) a designed substrate; and (iii) a reporter protein.
Correction is required.
Pertinent references
Selvaraj et al. (US Application Publication 20230190916 A1) teach An isolated recombinant polypeptide comprising a SARS-CoV-2 S1 protein binding domain polypeptide and a GM-CSF polypeptide. They do not teach present nucleic acid of SEQ ID NO: 2 or the protein of SEQ ID NO: 1.
Tan et al. (US Application Publication 2005214890A1) discloses protease activity assay system for determination of cleavage of more than one recognition/cleavage site in a single assay. The assay relies on use of a fluorescent fusion substrate which comprises a purification module i.e. His-tag, or poly (histidine), a first fluorescent protein (FP1), a specific protease recognition/scission site i.e. a SARS protease, a second fluorescent protein (FP2) and a matrix binding module i.e. cellulose binding domain. They do not teach present nucleic acid of SEQ ID NO: 2 or the protein of SEQ ID NO: 1.
Berdichevsky et al.: (A novel high throughput screening assay for HCV NS3 serine protease inhibitors, Journal of Virological Methods 107 (2003) 245-255) discloses novel assay for measurement of Hepatitis C virus (HCV) NS3 serine protease activity was developed for screening of HCV NS3 serine protease potential inhibitors. Recombinant NS3 serine protease was isolated and purified, and a fluorometric assay for NS3 proteolytic activity was developed. As an NS3 substrate we engineered a recombinant fusion protein where a green fluorescent protein is linked to a cellulose-binding domain via the NS5A/B site that is cleavable by NS3. Cleavage of this substrate by NS3 results in emission of fluorescent light that is easily detected and quantitated by fluorometry. They do not teach present nucleic acid of SEQ ID NO: 2 or the protein of SEQ ID NO: 1.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
